Trial processes involve significant work. To make them efficient and effective, an organized clinical data management plan must be in place.
ACRP 2021 programming offers practical strategies, best practices and innovative solutions to enhance clinical trial quality. Gain an in-depth view of all phases of trial design including feasibility, study design and more.
Feasibility
Clinical trial management is an inherently complex and specialist role, yet often falls outside the domains of research or professional support services. Due to an absence of recognition and career growth opportunities for this role, many in it feel undervalued in their roles.
Though a basic understanding of business concepts and processes is necessary, this role demands additional skills that enable effective design and conduct of high quality clinical trials. A strong project management approach is paramount to its successful running; unfortunately, most clinical trial managers lack formal project management training or access to central resources for support in this regard.
Complex clinical trials and their rate of change can quickly overwhelm a manager’s capacity to identify and respond quickly to issues, particularly as workforces become geographically dispersed and requests increase in frequency.
So a CTMS system that enables you to centralize research operations and make data-driven decisions is an integral component of success for any research site. CTMS systems help optimize site performance and help meet research goals; Advarra offers two systems to assist your site with optimizing research operations: OnCore Enterprise Research System is best suited for academic medical centers and cancer centers with large research volumes while Clinical Conductor is tailored for smaller health systems, research sites, and site networks. Contact us now and discover more how our software could benefit your research operation!
Study Design
At the outset of a clinical trial, selecting an appropriate study design can have regulatory, funder policy and journal publication repercussions. Furthermore, the type of study chosen also influences which participants receive either placebo or active treatment and what health outcomes are observed; selecting participants wisely allows researchers to answer whether an intervention influences certain health outcomes while improper selection could result in inaccurate or biased conclusions being reached by researchers.
Socioeconomic circumstances of potential study subjects can significantly determine their availability to participate in clinical trials. Depending on their financial status, they may pay for their own healthcare or be covered under a national health system. Some countries impose cultural or political barriers that preclude certain groups from joining clinical trials – in such instances it may be necessary to hire the services of a recruitment agency to help secure participants.
Once a study is underway, one of the greatest challenges for clinical trial managers is ensuring accurate monitoring and data capture across sites. Lacking electronic systems for centralized monitoring and reporting makes it more challenging to quickly compare results between sites or track individual site director performances.
As part of an effort to attract more individuals into clinical trial manager positions, it is vital that an accurate and diverse job description and career pathways be published and discussed openly, according to UKTMN [10]. Furthermore, affordable yet compliant data management platforms must be included as funding applications and integrated into existing systems of data capture systems.
Recruiting Sites
Successful trials depend on having investigators who feel like they’re part of an important team that’s answering an important clinical question. Therefore, any communication must be tailored specifically for each investigator involved and provide regular updates regarding both general progress as well as in their trial – this way keeping everyone aware of how their contributions contribute towards its success.
To achieve this goal, trial managers must be adequately educated in all aspects of delivering clinical trials, their roles in overseeing them correctly, and all training methods (one-on-one sessions, group trainings and distance learning methods such as video teleconferencing). To meet this standard of training.
An outstanding CTMS will aid researchers in planning and scheduling participant visits, which can boost engagement rates and reduce dropout rates while providing robust reporting and analytics that support decision-making.
Prior to CTMS, pharmaceutical and biotechnology companies often relied on manual spreadsheets for tracking various aspects of trials such as enrollment, financial metrics and regulatory documents. CTMS eliminates much of this administrative burden while providing one source of truth for all trial information.
Trial management has historically been seen as a supporting role, leaving some trial managers feeling underappreciated for the essential work they do to deliver high-quality trials. To combat this situation, more defined job descriptions and career pathways must be put in place so that trial managers’ role is fully recognized in research landscape.
Data Management
Clinical trial processes involve collecting an immense amount of data. To ensure this data remains clean and accurate, regular database audits should be performed to test if changes to any records have occurred as part of fraudulent manipulation attempts; they also help ensure data remains consistent over time.
Clinical trial managers play a vital role in planning and organizing the collection, storage and management of clinical trial data. It is vital that human and financial resources allocated towards running clinical trials be used efficiently; so creating an actionable project management plan from day one is imperative.
Many courses and workshops that provide training to clinical trial managers include project management skills training as this can be crucial in helping prevent major pitfalls from appearing during trials due to lack of a comprehensive method for running them.
Tracking and optimizing clinical trial activities are two critical components of data management for clinical trials. One approach is using a clinical trial management system (CTMS). CTMS software specifically tailored for clinical research allows centralized planning, reporting, tracking and optimization across all aspects of a trial including regulatory compliance reporting.
CTMSs can make clinical trials more efficient and cost-effective while increasing data quality, building trust with regulatory agencies and helping reduce manual work needed to prepare and submit regulatory reports. They may even help save costs through streamlining processes.
Study Closure
Closeout is the final phase in clinical trial management system. Here, any remaining tasks from the study trial are reconciled, documented, reported and completed – this includes reviewing final data to ensure its accuracy as well as cleaning it by identifying any incorrect or duplicate information that needs updating or correcting. Ideally this activity should occur throughout a trial but especially so at its closeout stage.
At this stage, all records should be reviewed and a final report submitted to the IRB. A closure request xform can be submitted in OneAegis (formerly IRBManager) if your study no longer needs ongoing review, while for ongoing reviews you will use the Continuing Review form instead. HRPP staff or an IRB Chair will review your closure request xform before either approving or declining it and notifying the Principal Investigator accordingly.
As part of the closure process, an official visit from a sponsor monitor to the site usually occurs as well. This visit involves reviewing CRFs, drug accountability files and regulatory files. Any medications or supplies used during the study will either be destroyed or returned back to its sponsor based on disposition authority policies such as wallet cards, waybills and prescription labels.
Remind all investigators that a study can only be closed once all research activities have been completed; otherwise it cannot be finished successfully. Therefore, when designing their studies they should bear this policy in mind and consider if their study can be concluded successfully or not.
